Study in Patients With Unresectable And Metastatic Melanoma: The Optimize Study

Completed

Conditions studied: Melanoma

In brief

This study evaluates the different patterns of care for patients who have unresectable or metastatic melanoma. The dosing, duration, regimen, indication, and treatments will be observed. The survival rate of these patients will also be observed.

Key facts

Study ID

NCT02780089

Run by

Bristol-Myers Squibb

People needed

408

Starts

2015-10-23

Expected to finish

2020-09-08

Last updated by the study team

2022-05-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Prospective cohort patients:
• Diagnosis date must occur on or after March 24, 2011 (date of ipilimumab approval in US)
• Diagnosis of stage III (unresectable) or stage IV melanoma (includes mucosal, uveal acral-lentiginous, leptomeningeal disease)
• Age ≥ 18 years at time of entry into study
• Patients must be actively receiving or scheduled to receive systemic treatment (any line, eg, first, second, third line [including investigational drugs]).
• For patients initiating new treatment, treatment must be started within 28 days after signing informed consent.
• For patients currently receiving treatment, patients must enroll within the first 21 days of starting new treatment
• Retrospective cohort patients:
• Patients with diagnosis of confirmed unresectable stage III or stage IV melanoma (including mucosal, uveal, acral-lentiginous, leptomeningeal disease)
• Age ≥ 18 years at time of unresectable or metastatic melanoma diagnosis
• Initiated therapy for unresectable or metastatic melanoma within 4 years prior to approval of ipilimumab (first immune checkpoint inhibitor therapy approved in US)
• March 25, 2007 - March 24, 2011
• One year of follow-up data is required from date of therapy initiation, if a patient passed away within the one year of follow-up; such patients are still eligible and the date of death will be collected.
• If retrospective patients have at least one year of follow-up data and are then treated with immuno-oncology, immune checkpoint inhibitor therapy, or targeted therapy, these patients will be analyzed separately.

You may not qualify if…

• Prospective patients:
• Patients participating in a clinical study that does not allow enrollment into a non interventional study or clinical studies in which the investigational treatment is blinded
• Patients who started new treatment > 21 days
• Patients who enrolled in study but did not initiate treatment before 28 days
• Patients with current malignancies (except non-melanoma skin cancer and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast) that requires additional systemic therapy

Where it is running

• Genesis Cancer Center — Hot Springs, Arkansas, United States
• Pacific Shores Medical Group — Long Beach, California, United States
• Cancer Care Associates — Redondo Beach, California, United States
• University of Colorado — Aurora, Colorado, United States
• 21st Century Oncology — Jacksonville, Florida, United States
• Cancer Specialits, LLC D/B/A — Jacksonville, Florida, United States
• Lakeland Regional Health — Lakeland, Florida, United States
• Watson Clinical Center for Research, INC — Lakeland, Florida, United States
• UF Health Cancer Center at Orlando Health — Longwood, Florida, United States
• Mount Sinai Medical Center — Miami Beach, Florida, United States
• Mid Florida Hematology and Oncology Centers — Orange City, Florida, United States
• Sacred Heart Medical Oncology Group — Pensacola, Florida, United States
• Tallahassee Memorial Healthcare — Tallahassee, Florida, United States
• H. Lee Moffitt Cancer Center Moffitt Cancer Center — Tampa, Florida, United States
• Harbin Clinic — Rome, Georgia, United States
• Summit Cancer Care — Savannah, Georgia, United States
• The Queen's Medical Center — Honolulu, Hawaii, United States
• North Shore University Health System — Evanston, Illinois, United States
• Ingalls Cancer Research Center — Harvey, Illinois, United States
• Oncology Specialits, S.C. — Niles, Illinois, United States
• Orchard Healthcare Research Inc. — Skokie, Illinois, United States
• Simmons Cancer Institute at SIU School of Medicine — Springfield, Illinois, United States
• Stormont-Vail Cancer Center — Topeka, Kansas, United States
• University of Kansas Medical Center — Westwood, Kansas, United States
• Northwest Alabama Cancer Center — Muscle Shoals, Alabama, United States

Full record on ClinicalTrials.gov

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